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The Nijmegen Hemostasis Assay: Simultaneous Fluorogenic Measurement of Thrombin and Plasmin Generation in a Single Well

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Recommendations for appropriate activated partial thromboplastin time reagent selection and utilization.

George A Fritsma¹, Francine R Dembitzer, Ankush Randhawa

¹Department of Pathology and Division of Laboratory Medicine, School of Medicine, University of Alabama at Birmingham, Birmingham, AL, USA.

American Journal of Clinical Pathology

|May 16, 2012

Summary

Activated partial thromboplastin time (aPTT) reagent choice impacts lupus anticoagulant (LA) detection. Most labs use LA-responsive reagents for routine testing, but low-responsive reagents are recommended for factor deficiencies and heparin monitoring.

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Area of Science:

Clinical Chemistry
Hematology
Coagulation Diagnostics

Background:

The activated partial thromboplastin time (aPTT) is a critical screening test for coagulation disorders and monitoring unfractionated heparin.
Commercial aPTT reagents exhibit variable performance, especially in detecting the lupus anticoagulant (LA).
Reagent selection significantly influences the interpretation of aPTT results.

Purpose of the Study:

To investigate the basis for activated partial thromboplastin time (aPTT) reagent selection in clinical laboratories.
To assess laboratory practices regarding aPTT reagent responsiveness to the lupus anticoagulant (LA).
To identify misunderstandings in aPTT reagent use for routine testing versus LA identification.

Main Methods:

Analysis of College of American Pathologists proficiency testing data from ~4,000 coagulation laboratories.
A survey of 93 coagulation laboratories was conducted via The Fritsma Factor hemostasis website.
Evaluation of aPTT reagent selection criteria and practices.

Main Results:

Most laboratories utilize aPTT reagents with high or moderate responsiveness to LA for routine testing.
A significant gap in understanding was observed concerning the appropriate aPTT reagent for routine screening versus LA detection.
Laboratory practices do not consistently align with recommendations for specific diagnostic scenarios.

Conclusions:

Low LA-responsive aPTT reagents are recommended for screening coagulation factor deficiencies and monitoring heparin therapy.
High/moderate LA-responsive aPTT reagents may be suitable for LA screening but not routine testing.
Enhanced education is needed for laboratory professionals and manufacturers on appropriate aPTT reagent selection and use.